HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site
HEAL Initiative:新生儿阿片类药物戒断综合征药物治疗效果比较试验新墨西哥州网站
基本信息
- 批准号:10378942
- 负责人:
- 金额:$ 44.54万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-17 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:Admission activityAge-MonthsAssessment toolBuprenorphineCaringDevelopmentDoseDrug ExposureEnsureEvaluationGrowthHealth BenefitHelping to End Addiction Long-termHospitalsInfantInstitutionLatinxLengthLength of StayMethadoneMethamphetamineMexicanMorphineMothersNative AmericansNeonatalNeonatal Abstinence SyndromeNeonatal Intensive Care UnitsNew MexicoNewborn InfantNurseriesNursing ResearchOutcomeOutcome MeasurePerinatalPharmaceutical PreparationsPharmacological TreatmentPopulationPrincipal InvestigatorProtocols documentationPublic HealthRandomizedRandomized Controlled TrialsRecording of previous eventsRegimenResearchResearch PersonnelResearch SubjectsSelective Serotonin Reuptake InhibitorSeriesSiteStandardizationTimeTobacco useToddlerTreatment CostUniversitiesWeaningWomanclinical centerclinically relevantcomparative effectivenesscomparative effectiveness studycomparative effectiveness trialdesignexperiencefollow-upimprovedmaternal opioid usemulti-ethnicneonatal careneonateneurodevelopmentnon-opioid analgesicopioid epidemicopioid useopioid use disorderoptimal treatmentspolysubstance userecruitstudy population
项目摘要
Project Summary/Abstract
The Neonatal Opioid Withdrawal Syndrome (NOWS) Pharmacological Treatments Comparative
Effectiveness Trial is a multisite study that examine the long- and short-term outcomes for neonates with
NOWS that require pharmacological treatment. The neonates will be randomized to three medications:
buprenorphine, methadone and morphine. Short term outcomes are anticipated to include length of hospital
stay and length of pharmacological treatment, with longer term outcomes including neonatal growth and
neurodevelopment. The common protocol will be developed by a steering committee composed of the
principal investigators from each participating clinical center. The trial will be designed to control for relevant
clinical variables including the type of maternal opioid used, maternal polysubstance use including tobacco,
the use of nonpharmacological treatments for NOWS, and the use of adjunctive nonopioid medications. The
follow-up plan will be developed as part of the protocol and will extend until at least 24 months of age and
include the use of specific neurodevelopmental assessment tools including the Bayley Scales of Infant and
Toddler Development 4th Edition. The trial is designed to determine the optimal pharmacological treatment
including the specific medication dosing and weaning regimen. The University of New Mexico Clinical Center
will include infants treated for NOWS across all neonatal care sites including the mother baby unit where
dyadic room-in care is provided, the intermediate care nursery, and the neonatal intensive care unit. The
standardization of pharmacological treatment for NOWS is anticipated to have significant public health
benefits including decreasing length of hospital stay, decreasing cost of treatment, and potentially improving
long term neurodevelopmental outcomes.
项目摘要/摘要
新生儿阿片类药物戒断综合征(NOWS)的药理治疗比较
有效性试验是一项多点研究,旨在检查患有糖尿病的新生儿的长期和短期结果
现在需要药物治疗。新生儿将被随机分成三种药物:
丁丙诺啡、美沙酮和吗啡。短期结果预计包括住院时间。
药物治疗的住院时间和持续时间,包括新生儿生长和
神经发育。共同议定书将由一个指导委员会制定,该委员会由
各参与临床中心的首席研究人员。该试验将设计为控制相关的
临床变量包括母亲使用的阿片类药物的类型,母亲使用包括烟草在内的多种物质,
非药物治疗NOW的使用,以及辅助非阿片类药物的使用。这个
后续计划将作为议定书的一部分制定,并将延长到至少24个月龄和
包括使用特定的神经发育评估工具,包括贝利婴儿和
《幼儿发展》第四版。该试验旨在确定最佳的药物治疗。
包括具体用药剂量和断奶方案。新墨西哥大学临床中心
将包括在所有新生儿护理地点接受NOWS治疗的婴儿,包括母婴病房
提供二元室内护理、中级护理托儿所和新生儿重症监护病房。这个
NOWS药物治疗的标准化有望对公众健康产生重大影响
好处包括减少住院时间,降低治疗成本,并有可能改善
长期的神经发育结果。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('LAWRENCE M LEEMAN', 18)}}的其他基金
HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site
HEAL Initiative:新生儿阿片类药物戒断综合征药物治疗效果比较试验新墨西哥州网站
- 批准号:
10891302 - 财政年份:2021
- 资助金额:
$ 44.54万 - 项目类别: